Full Press Release Details
Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update
ARCALYST (rilonacept) Q3 2022 net revenue of $33.4 million -
RHAPSODY long-term extension data demonstrated rilonacept treatment beyond 18 months resulted in continued treatment response (Hazard
Ratio = 0.018, p<0.0001) -
KPL-404 Phase 2 data in rheumatoid arthritis expected in 1H 2024 -
Cash reserves of $200.7 million expected to fund operations into at least 2025 -
Conference call and webcast scheduled for 8:30 am ET today -
BERMUDA - November 1, 2022
- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed
to modulate immunological pathways across a spectrum of diseases, today reported third quarter 2022 financial results and provided a
"Physician adoption,
patient satisfaction, and payer access drove continued strong ARCALYST performance in the third quarter. We remain focused on positioning
ARCALYST as the standard of care for recurrent pericarditis, with the goal of broadening our reach and helping even more patients,"
said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Additionally, with the profitable ARCALYST collaboration
and initial proceeds from the global license agreement with Genentech for the rights to develop and commercialize vixarelimab, we are
well-positioned to execute on synergistic growth opportunities across our portfolio, including the expansion of our ARCALYST cardiovascular
and IL-1 cytokine trap)
antibody inhibitor of CD40-CD154 interaction)
Mavrilimumab (monoclonal
antibody inhibitor targeting GM-CSFR )
Scientific Conference Presentation
Imazio of University Hospital Santa Maria della Misericordia, Udine, will present a poster presentation entitled Prolonged Rilonacept
Treatment in RHAPSODY Long-Term Extension Provided Persistent Reduction of Pericarditis Recurrence Risk on Sunday, November 6, 2022,
from 3:45 to 4:45 p.m. Central Time (4:45 - 5:45 p.m. Eastern Time).
in the abstract are as of the abstract cutoff date; final data are under embargo until the poster presentation.
3 Upon commercial availability
of ARCALYST for recurrent pericarditis in April 2021, the LTE portion in the US ended, and patients continuing therapy transitioned to
commercial ARCALYST. Non-US patients remained in the LTE without interruption until the LTE closed in June 2022.
is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients
suffering from debilitating diseases with significant unmet medical need. Kiniksa's portfolio assets, ARCALYST, KPL-404, and mavrilimumab,
are based on strong biologic rationale or validated mechanisms, target underserved conditions, and offer the potential for differentiation.
These assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit www.kiniksa.com.
is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1 ) and interleukin-1
beta (IL-1 ) signaling. ARCALYST was discovered by Regeneron and is approved by the U.S. Food and Drug Administration (FDA) for
recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells
Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment
of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020. The European Commission
granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2020.
ARCALYST is indicated
SAFETY INFORMATION ABOUT ARCALYST
more information about ARCALYST, talk to your doctor and see the Product Information.
is an investigational humanized monoclonal antibody that is designed to inhibit CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory
signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the
CD40-CD154 interaction is an attractive approach to address multiple autoimmune disease pathologies.
is an investigational fully human monoclonal antibody that blocks activity of GM-CSF by specifically binding to the alpha subunit of
the GM-CSF receptor (GM-CSFR ). Phase 2 clinical trials of mavrilimumab in rheumatoid arthritis and giant cell arteritis achieved
their primary and secondary endpoints with statistical significance. Kiniksa is evaluating the development of mavrilimumab in rare cardiovascular
diseases where the GM-CSF mechanism has been implicated.
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify
forward looking statements by terms such as "may," "will," "should," "expect," "plan,"
"anticipate," "could," "intend," "target," "project," "contemplate,"
"believe," "estimate," "predict," "potential" or "continue" or the negative
of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements
contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including
without limitation, statements regarding: positioning ARCALYST as the standard of care for recurrent pericarditis with the goal of broadening
our reach and helping even more patients; our ability to execute on synergistic growth opportunities across our portfolio, including
the expansion of our ARCALYST cardiovascular franchise; our expectation that (i) the proof-of-concept portion of the Phase 2 clinical
trial of KPL-404 in rheumatoid arthritis will begin after completion of the multiple ascending dose portion of such trial, and (ii) we
will report data from such Phase 2 clinical trial in the first half of 2024; our pursuit of collaborative study agreements to evaluate
the potential of mavrilimumab in rare cardiovascular diseases where the GM-CSF mechanism has been implicated; our expectation that ARCALYST
net revenue for full-year 2022 will be between $115 million and $130 million; our expectation about our cash reserves funding our current
operating plan into at least 2025; our beliefs about the mechanisms of action of our product candidates and potential impact of their
approach, including that using KPL-404 to disrupt the CD40-CD154 interaction is an attractive approach to address multiple autoimmune
disease pathologies; and our belief that all of our product candidates offer the potential for differentiation.
These forward-looking
statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without
limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical
trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any
preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials
or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive
or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability
to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities
to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval;
inability to successfully execute on our commercial strategy for ARCALYST; our reliance on third parties as the sole source of supply
of the drug substance and drug product used in our products and product candidates; our reliance on Regeneron as the sole manufacturer
of ARCALYST; raw materials, important ancillary products and drug substance and/or drug product shortages; our reliance on third parties
to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating
requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; the impact of the COVID-19
pandemic and any subsequent pandemic and measures taken in response to such pandemics on our business and operations as well as the business
and operations of our manufacturers, CROs upon whom we rely to conduct our clinical trials, and other third parties with whom we conduct
business or otherwise engage, including the FDA and other regulatory authorities; changes in our operating plan and funding requirements;
and existing or new competition.
These and other important
factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption "Risk Factors"
contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent management's estimates as of the date of this press release. Except
as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking
statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
a registered trademark of Regeneron Pharmaceuticals, Inc. All other trademarks are the property of their respective
Kiniksa Investor and
PHARMACEUTICALS, LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue, net | $ | 33,424 | $ | 12,095 | $ | 82,585 | $ | 19,799 | ||||||||
| License and collaboration revenue | 65,711 | - | 75,711 | - | ||||||||||||
| Total revenue | 99,135 | 12,095 | 158,296 | 19,799 | ||||||||||||
| Costs and operating expenses: | ||||||||||||||||
| Cost of goods sold | 6,937 | 2,767 | 16,185 | 5,233 | ||||||||||||
| Collaboration expenses | 4,623 | - | 16,549 | - | ||||||||||||
| Research and development | 16,485 | 19,236 | 51,100 | 71,864 | ||||||||||||
| Selling, general and administrative | 24,677 | 20,759 | 70,736 | 63,207 | ||||||||||||
| Total operating expenses | 52,722 | 42,762 | 154,570 | 140,304 | ||||||||||||
| Income (loss) from operations | 46,413 | (30,667 | ) | 3,726 | (120,505 | ) | ||||||||||
| Interest income | 322 | 5 | 459 | 20 | ||||||||||||
| Income (loss) before income taxes | 46,735 | (30,662 | ) | 4,185 | (120,485 | ) | ||||||||||
| Benefit (provision) for income taxes | 177,358 | 118 | 174,717 | (1,106 | ) | |||||||||||
| Net income (loss) | $ | 224,093 | $ | (30,544 | ) | $ | 178,902 | $ | (121,591 | ) | ||||||
| Net income (loss) per share attributable to common shareholders-basic | $ | 3.23 | $ | (0.44 | ) | $ | 2.58 | $ | (1.78 | ) | ||||||
| Net income (loss) per share attributable to common shareholders-diluted | $ | 3.18 | $ | (0.44 | ) | $ | 2.55 | $ | (1.78 | ) | ||||||
| Weighted average common shares outstanding-basic | 69,445,071 | 68,662,673 | 69,305,755 | 68,444,061 | ||||||||||||
| Weighted average common shares outstanding-diluted | 70,552,018 | 68,662,673 | 70,286,444 | 68,444,061 |
PHARMACEUTICALS, LTD.
CONSOLIDATED BALANCE SHEET DATA
| As of | ||||||||
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 200,724 | $ | 182,201 | ||||
| Working capital | 185,323 | 151,622 | ||||||
| Total assets | 459,953 | 232,800 | ||||||
| Accumulated deficit | (496,495 | ) | (675,397 | ) | ||||
| Total shareholders' equity | 384,008 | 185,037 |